Multicenter, Platform-type Clinical Study of Refractory/Recurrent Acute Myeloid Leukemia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Ivosidenib, Venetoclax, Gilteritinib, Homoharringtonine.
- Who it may be relevant to
- Registry conditions: AML, Refractory, Relapsed. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
To study the optimal therapeutic strategies for salvage treatment of refractory/relapsed AML, and to clarify the effectiveness and safety of various salvage treatment options. A prospective, multicenter, platform-type study was conducted to explore the overall response rate, tolerability, and survival of patients with R/R AML with different treatment regimens.
Interventions
- Drug Ivosidenib
in arm 1 - Drug Venetoclax
in arms 2-5 - Drug Gilteritinib
in arm 2 - Drug Homoharringtonine
in arms 4 and 7 - Drug Cytarabine
in arms 3 and 7 - Drug Daunorubicin/ Idarubicin /Mitoxantrone
in arms 3 and 7 - Drug Azacitidine
in arms 1，2 , 5 and 8 - Drug Lisaftoclax
in arms 7 and 8 - Drug PI3K inhibitors, histone deacetylase inhibitors, selinexor, novel liposomal drugs, and others
in arm 6
Primary outcome measures
- Complex response (CRc) rate (including CR and CRi) [Time frame: up to 4 years]
Secondary outcome measures (5)
- mortality associated with salvage treatment (30 days, 60 days) [Time frame: Treatment within 30 days and 60 days]
- MRD-negative complete response rate [Time frame: the whole period of the trial, up to 730 days]
- Overall survival [Time frame: the whole period of the trial, up to 730 days]
- Event-free survival [Time frame: the whole period of the trial, up to 730 days]
- Relapse-free survival [Time frame: the whole period of the trial, up to 730 days.]
Eligibility criteria
Inclusion criteria
- 1\. Patients with acute myeloid leukemia (except for acute promyelocytic leukemia) diagnosed by bone marrow cell morphology, immunology and genetics above are classified according to the French-British-American Collaboration diagnostic criteria (FAB criteria) and the World Health Organization diagnostic criteria (WHO2016 criteria).
2\. Meet criteria for refractory/recurrent AML (except APL). The recurrence was morphological recurrence, excluding molecular recurrence. Except for simple extramedullary leukemia.
3\. Age and gender are not limited. 4. Informed consent must be signed before the start of the study procedure, and the informed consent must be signed by the patient himself or his immediate family if he is 18 years old and above; For young patients under the age of 18, the legal guardian shall sign the informed consent. Considering the patient's condition, if the patient's signature is not conducive to the treatment of the condition, the informed consent shall be signed by the legal guardian or the patient's immediate family.
Exclusion criteria
- Concurrent malignant tumors of other organs (patients requiring treatment).
- Participants considered unsuitable for inclusion by the researchers.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Blood Hospital — Tianjin
Identifiers
NCT: NCT06265545 · IIT2024001